Federal Regulatory Officer for Protection of Human Subjects

Tom Puglisi, PhD
Federal Office for Protection from Research Risks

It was Spring of 1979, and I was a first-year faculty member. The dean asked our department chair to nominate someone to head the "Human Subjects Committee." Eager to advance my fledgling career, and believing that chairing a university committee might help when tenure time rolled around, I volunteered. Now, 20 years later, I'm still in the business of protecting human subjects — currently as director of Human Subject Protections in the Federal Office for Protection from Research Risks (OPRR).

Trained as a lifespan developmental psychologist, I never dreamed that I would end up a federal bureaucrat. However, I should have realized I would be influenced by the same developmental challenges, choice points and just plain random events that influence everyone else. By 1986, having taught a variety of psychology courses, coordinated our interdisciplinary gerontology program, received research grants, published respectably and been awarded tenure, I was ready for a change. Always interested in politics, the APA/AAAS Congressional Science Fellowship Program seemed like the perfect opportunity to round out my gerontology expertise.

The Congressional Fellowship was a tremendous experience. Working with the now-defunct Select Committee on Aging in the House of Representatives, I networked in gerontology, developed mental health amendments to the Older Americans Act, became conversant about health policy and learned more than I could imagine about the federal budget. I drafted statements for the Congressional Record, wrote press releases, formulated a three-pronged initiative to enhance elderly mental health, and ghost-authored an American Psychologist® article for my boss.

In spite of its rewards, however, the harried life of a congressional staffer seemed too unpredictable for me to maintain over the long term. I returned to academia in search of a "normal" life, but soon found myself unhappy and missing day-to-day involvement in national issues. Moreover, the congressional experience led to the realization that my training as a psychologist had equipped me with analytical skills that could be applied to a wide range of interesting and challenging work.

Then luck intervened. One afternoon in June 1989, I received an unexpected call from OPRR, which enforces the Department of Health and Human Services (HHS) Regulations for the Protection of Human Subjects. Someone in OPRR had identified me as an experienced Institutional Review Board (IRB) chair who might be interested in a job in Washington, D.C.

OPRR's Division of Human Subject Protections performs three statutory functions: providing guidance on ethical issues in human subject research; negotiating written commitments (called "Assurances") from institutions to establish appropriate protections for human subjects; and exercising oversight to ensure compliance with human subject protection requirements.

I have found this work to be infinitely challenging and stimulating. For many years, I was the only behavioral scientist in OPRR, so I became the resident expert for questions involving behavioral research. It has been especially rewarding for me to help behavioral scientists understand regulations that may seem complex and oriented toward biomedical research, and to help biomedical scientists understand how the regulations should be applied in behavioral contexts. Sometimes it helps simply to point out that IRBs reviewing behavioral research must (by regulation) include the expertise needed to review behavioral research fairly.

The greatest challenge for me, and the greatest reward, has been the struggle to weigh appropriately the primacy of protecting individual human subjects from physical and dignitary harm against the potentially critical benefits to society of cutting-edge research.

Over the years, my OPRR colleagues and I have been faced with making difficult (and controversial) determinations about such issues as the adequacy of informed consent for schizophrenia research; revising the regulations governing pregnant women and fetuses in research; the ethical propriety of AIDS vaccine research and HIV vertical transmission research in economically deprived countries; the appropriateness of fenfluramine challenge designs in psychiatric research involving children; and the ethical, legal and regulatory ramifications of surreptitious egg and embryo "swapping" by nationally recognized fertility researchers (now convicted on federal felony charges). I have twice been called before congressional committees to explain OPRR's determinations concerning politically charged issues (informed consent in tamoxifen breast cancer research, and the shutdown of research at a large Veterans Affairs Medical Center).

Within the next few months, OPRR will be moving from its position within the National Institutes of Health to the Office of the Secretary of HHS. From this more lofty and visible perch, OPRR will be able to exercise greater leadership within HHS and among the other federal agencies conducting human subject research. A new National Advisory Committee will be created to help OPRR address the most complex ethical and policy issues that have, up to now, been beyond OPRR's expertise. These changes promise to be invigorating, if somewhat daunting.

In short, I could not imagine a more fascinating and rewarding professional endeavor. I love my job, and look forward every day to the never ending challenges that it presents.

(Originally published in the January/February 1998 issue of Psychological Science Agenda, the newsletter of the APA Science Directorate.)